Kornimate/medical-research-clean huggingface dataset:
study to test the safety and how well patients with severe hemophilia a respond to treatment with bay 2599023 (dtx 201), a drug therapy that delivers a healthy version of the defective factor viii gene into the nucleus of liver cells using an altered, non-infectious virus (aav) as a "shuttle"

Conditions: Hemophilia A

Summary: in this study researchers want to gather more information about safety and effectiveness of bay 2599023 (dtx201), a drug therapy that delivers the human factor viii gene into the human body by use of a viral vector to treat the disease. by replacing the defective gene with a healthy copy the human body may produce clotting factor on its own. hemophilia a is a bleeding disorder in which the human body does not have enough clotting factor viii, a protein that controls bleeding. researcher want to find the optimal dose of bay 2599023 (dtx201) so that the body may produce enough clotting factor on its own.


Eligibility criteria:
inclusion criteria: * males age 18 years or older. * confirmed diagnosis of hemophilia a as evidenced by their medical history with plasma fviii activity levels \< 1% of normal or at screening. * have \>150 exposure days (eds) to fviii concentrates (recombinant or plasma-derived). if on prophylaxis, are required to be willing to stop prophylactic treatment at specified time points throughout the study or if on-demand: should have had \> 4 bleeding events in the last 52 weeks - agree to use reliable barrier contraception. exclusion criteria: * history of allergic reaction to any fviii product. * clinically relevant findings in the physical examination considered critical by the treating physician, including obesity with bmi \> 35 kg/m\*2 * current evidence of measurable inhibitor against factor viii, prior history of inhibitors to fviii protein or clinical history suggestive of inhibitor. * evidence of active hepatitis b or c. * currently on antiviral therapy for hepatitis b or c. * significant underlying liver disease. * serological evidence of hiv-1 or hiv-2 with cd4 counts ≤200/mm\*3; hiv+ and stable participants with cd4 count \>200/mm\*3 and undetectable viral load are eligible to enroll. * detectable antibodies reactive with aavhu37capsid. * participant with another bleeding disorder that is different from hemophilia a (e.g., von willebrand disease, hemophilia b). * participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational product within the last 12 weeks. * known or suspected hypersensitivity or allergic reaction to trial product(s) or related fviii products or any component of bay2599023 (dtx201), or a contraindication to prednisolone

Keywords: severe hemophilia a (<1% fviii activity) factor viii gene therapy
an efficacy and safety study of low-dose transdermal therapeutic system (tts)-fentanyl d-trans in taiwan participants with cancer pain

Conditions: Cancer, Pain

Summary: the purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (tts \[medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream\]) - fentanyl in taiwan participants with cancer pain. secondly, to demonstrate the dropout rate that will be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25 mcg/h.

this is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm, non-randomized study to evaluate the efficacy and safety of low-dose tts-fentanyl in taiwan participants with cancer pain. eligible participants will be enrolled and scheduled to return at day 0, 7, 14 and 28. participants will receive tts-fentanyl for 28 days at a starting dose of 12 micrograms per hour (mcg/h) (one patch). dose of fentanyl can increased or decreased as per investigator's discretion to maintain participant's pain score at 2 or less on the brief pain inventory (bpi) question 6 (that tells how much pain you have right now). safety will primarily be evaluated by measuring participant's dropout rate due to adverse events. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants diagnosed with cancer; histologically (examination of tissue specimens under a microscope) confirmed malignancy (term for diseases in which abnormal cells divide without control and can invade nearby tissues) * participants who are able to communicate effectively with study personnel * participants who have intolerable cancer pain (pain score greater than or equal to \[\>=\] 4) * participants who have an estimated life expectancy of at least 30 days * participants who have given written dated informed consent to participate in the study exclusion criteria: * participants who have already received regular treatment with an strong opioid (morphine-like synthetic narcotic that produces the same effects as drugs derived from the opium poppy \[opiates\]), for their pain before entering the study * participants who have already received tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) treatment over 200 milligram (mg) for their pain before entering the study * participants with significant abnormalities in hepatic or renal function which would, in the opinion of the investigator, prevent the participants involvement in the study * participants with significant clinical abnormalities in central nervous system (cns), respiratory or cardiovascular function, which in the investigators judgment prevents participation in the study * pregnant or lactating females or females of child bearing potential not currently practicing documented, adequate contraception

Keywords: cancer pain pain fentanyl durogesic cancer transdermal
corpath grx stemi study

Conditions: STEMI - ST Elevation Myocardial Infarction; CAD

Summary: this study will evaluate the performance of the corpath grx system in robotic primary pci (rppci) in the treatment of st-elevated myocardial infarction (stemi).

this is a prospective, post-market, single-arm, multi-center, observational study to evaluate the performance of the corpath grx system during robotic-pci for acute st elevation myocardial infarction (stemi).

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤ 80 years * patients with stemi\<12 h of symptom onset * patient deemed appropriate for robotic-assisted pci * the subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent exclusion criteria: cardiogenic shock * cardiac arrest * need for manual or mechanical thrombectomy * failure/inability/unwillingness to provide informed consent * the investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary pci treatment
a phase ii trial of afatinib(bibw 2992) in third-line treatment for patients with stage iiib/iv adenocarcinoma of the lung harbouring wild-type epidermal growth factor receptor[egfr]

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: to explore the efficacy of bibw 2992 defined by the objective response rate (complete response, partial response) as determined by response evaluation criteria in solid tumours\[recist\] 1.1 in the patients with advanced (stage iiib or iv) adenocarcinoma of the lung harbouring wild-type egfr.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed stage iiib/iv adenocarcinoma in non-small cell lung cancer\[nsclc\] 2. progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen 3. a known wild-type egfr status 4. patients 18 years of age or older exclusion criteria: 1. more than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease 2. prior treatment with egfr targeting small molecules or antibodies 3. radiotherapy or surgery within 4 weeks prior to study entry 4. active brain metastasis 5. known pre-existing interstitial lung disease 6. history or presence of clinically relevant cardiovascular abnormalities 7. cardiac left ventricular function with resting ejection fraction of less than 50% 8. absolute neutrophil count\[anc\] \< 1,500/mm3 9. platelet count \<100,000/mm3 10. creatinine clearance\ 1.5 times upper limit of normal 11. women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial 12. pregnancy or breast-feeding
ketum and pain tolerence

Conditions: Pain

Summary: the study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.

participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. the study is a placebo-controlled, double-blind within-subject repeated mesaures design. participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at usm centre for drug research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.

Eligibility criteria:
inclusion criteria: individuals who report drinking ketum decoction more than once a day, daily for the past 12 months. - exclusion criteria: (1) tested positive for illicit drug use including morphine, cannabis, methamphetamine, amphetamine, methadone, benzodiazepine and ketamine; (2) have current or previous history of psychological or neurological problems (self-report); (3) have current or previous alcohol use history (self-report); (4) hiv infections; (5) history of chronic liver disease (e.g. cirrhosis, hepatitis a, b, c, etc.) 6) non-alcoholic fatty liver disease; (7) history of coronary heart disease and diabetes; (8) existing chronic pain condition and (9) history of psychiatric disorders. exclusion criteria for female particiapns: (1) pregnancy, (2) nursing. -

Keywords: pain kratom ketum mitragynine
randomized study of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia

Conditions: Pre-eclampsia

Summary: objectives: i. determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.

protocol outline: this is a randomized, international, multicenter study. patients are randomized to receive either nimodipine or magnesium sulfate. arm i: patients receive nimodipine by mouth every 4 hours. treatment is continued until 24 hours post-partum. arm ii: patients receive a loading dose of magnesium sulfate iv for 20 minutes, followed by continuous infusion of magnesium sulfate. treatment is continued until 24 hours post-partum.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria: * blood pressure greater than 160/110 mmhg or mean arterial pressure of 126 mmhg * proteinuria greater than 5 g/24 hr * epigastric pain or right upper quadrant pain ast/alt greater than 70 u/l * severe headache and/or scotomata * thrombocytopenia as evidenced by: platelet count less than 100,000/mm3 disseminated intravascular coagulation microangiopathic hemolytic anemia oliguria (less than 400 ml/day or 30 ml/hr) * pulmonary edema --prior/concurrent therapy-- * no prior/concurrent magnesium sulfate or dihydropyridine agents * no other concurrent antiseizure medications --patient characteristics-- * age: not specified * performance status: not specified * hematopoietic: see disease characteristics * hepatic: see disease characteristics * renal: no severe renal failure see disease characteristics * cardiovascular: no history of angina or myocardial infarction no cardiac dysfunction no history or sign of congestive cardiac failure no arrhythmia with ventricular rate less than 60 bpm see disease characteristics * pulmonary: see disease characteristics --other:-- * no severe mental or physical disorder that may affect therapy * not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate * no evidence of fetal distress or fetal anomalies

Keywords: cardiovascular and respiratory diseases hypertensive disorder pre-eclampsia rare disease
clinical trial of gut microbiota in the management of immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: primary immune thrombocytopenia (itp) is an acquired autoimmune bleeding disorder, accounting for about 1/3 of clinical hemorrhagic diseases. loss of immune tolerance leading to increased platelet destruction and decreased platelet production is the main pathogenesis of itp. dysbiosis of the gut microbiota was found in many autoimmune diseases like rheumatic arthritis(ra),inflammatory bowel disease(ibd),multiple sclerosis and probiotic treatment or fecal microbiota transplantation(fmt) which can regulate the gut microbiota has good clinical efficacy in those disorders. one itp patient with ulcerative colitis(uc) was treated with fmt and got progressive but significant increase in platelet level and lasted for several years.

the investigators are undertaking a multicenter, single-arm study of 60 primary itp adult patients from 5 medical centers in china. all the participants are randomly divided into two groups to orally intake either probiotic supplements (n = 30) or placebo (n = 30) for 4 weeks in addition with high dose dexamethasone(40 mg/d for 4 days). platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. need of on-demand or adjunctive therapy alone does not qualify the patient as refractory * primary itp confirmed by excluding other supervened causes of thrombocytopenia exclusion criteria: * pregnancy * hypertension * cardiovascular disease * diabetes * liver and kidney function impairment * hcv, hiv, hbsag seropositive status * patients with systemic lupus erythematosus and/or antiphospholipid syndrome * patients with known gastro-intestinal bleeding. * use of antibiotics, prebiotics or probiotics in the past 4 weeks;

Keywords: gut microbiota immune thrombocytopenia
enhancing lung health in kids with structural lung damage and malformations: azithromycin (azi) for airway infection prevention

Conditions: Tracheomalacia; Bronchopulmonary Dysplasia (BPD); Vascular Ring; Cystic Lung Disease; Bronchiectasis; Chronic Atelectasis

Summary: children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. despite various interventions, effective strategies are urgently needed. the link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. although antibiotics can alleviate symptoms, relapse is common. experts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population. to address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. this research aims to inform clinical practice and improve the health of affected children and their families.


Eligibility criteria:
inclusion criteria: 1. ct and bronchoscopy verified and structural lung damage or congenital lung and airway malformations 2. outpatient affiliation with one of the three highly specialized pediatric pulmonology centers. 3. at risk of or already documented respiratory infections requiring antibiotics. 4. age between 0-72 months at inclusion. exclusion criteria: 1. asthmatic challenges: patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study. 2. cystic fibrosis (cf) or primary ciliary dyskinesia (pcd): patients with a cf or pcd diagnosis will be excluded. 3. impaired liver function: children with an alanine transaminase (alat) twice or more the upper limits of normal will be excluded. 4. impaired kidney function: children with a serum creatinine higher than the upper limit of normal for age will be excluded. 5. neurological or psychiatric disorders 6. prolonged qt interval: patients with either congenital or acquired prolonged qt interval will be excluded. 7. heart disease: patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study. 8. allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study.
paclitaxel in treating patients with locally advanced, metastatic, or recurrent cancer of the vulva

Conditions: Vulvar Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.

objectives: * determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva. * determine the objective response rate and duration of response in these patients treated with this drug. * determine the acute side effects of this drug in these patients. outline: this is a multicenter study. patients receive paclitaxel iv over 3 hours on day 1. treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 9 weeks. projected accrual: a total of 16-29 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the vulva * not suitable for radiotherapy or surgery as first-line treatment * measurable or evaluable disease * at least 1 bidimensionally measurable target lesion * measurable metastatic disease outside previously irradiated areas or * local recurrence within a previously treated area or * local lesions showing progression while on treatment * no brain metastasis patient characteristics: age: * 18 and over performance status: * who 0-2 * ecog 0-2 life expectancy: * at least 3 months hematopoietic: * not specified hepatic: * bilirubin no greater than 1.5 mg/dl * ast/alt less than 2 times upper limit of normal renal: * creatinine clearance greater than 60 ml/min cardiovascular: * no prior or concurrent cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmia requiring medication, or 2nd or 3rd degree heart block) other: * no peripheral neuropathy greater than grade 1 * no serious active infection * no prior allergic reaction to drugs containing cremophor el * no other serious medical, psychological, familial, or social condition that would preclude study * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy except as concurrent therapy with radiotherapy endocrine therapy: * not specified radiotherapy: * see disease characteristics * see chemotherapy * no concurrent radiotherapy surgery: * not specified

Keywords: stage iii vulvar cancer stage iv vulvar cancer recurrent vulvar cancer squamous cell carcinoma of the vulva
study of anlotinib in patients with metastatic colorectal cancer（mcrc）(alter0703)

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to compare the effects and safety of anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

anlotibib (al3818) is a kind of innovative medicines approved by state food and drug administration（sfda:2011l00661） which was researched by jiangsu chia-tai tianqing pharmaceutical co., ltd.to compare the effects and safety of anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent； 2. histological or cytological documentation of adenocarcinoma of the colon or rectum； 3. subjects with metastatic colorectal cancer (stage iv),with measurable disease (using recist1.1)； 4. progression during or within 3 months following the last administration of approved standard therapies which must include fluorouracil or its derivatives, oxaliplatin, irinotecan； 5. ecog ps:0-1,life expectancy of more than 3 months； 6. main organs function is normal； 7. main organs function is normal； exclusion criteria: 1. prior treatment with anlotinib； 2. major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug； 3. known brain metastases； 4. patients with severe and failed to controlled diseases； 5. patients occurred venous thromboembolic events within 6 months；

Keywords: anlotinib metastatic colorectal cancer （mcrc） alter0703
study of aripiprazole in subjects with alcoholism

Conditions: Alcoholism

Summary: the purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo. the safety of using aripiprazole will also be studied.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.